Purity
> 98% by SDS-PAGE and HPLC analyses.
Molecular Weight
Approximately 16.9 kDa, a single non-glycosylated polypeptide chain containing 144 amino acids.
Sequence
MQDPYVKEAE NLKKYFNAGH SDVADNGTLF LGILKNWKEE SDRKIMQSQI VSFYFKLFKN FKDDQSIQKS VETIKEDMNV KFFNSNKKKR DDFEKLTNYS VTDLNVQRKA IHELIQVMAE LSPAAKTGKR KRSQMLFRGR RASQ
Biological Activity
Assay #1: Fully biologically active when compared to standard. The ED50 as measured in anti-viral assays using human HeLa cells infected with encephalomyocarditis (EMC) virus is 0.15-0.80 ng/mL. The specific activity of recombinant human IFN-γ is > 1.0 × 107 IU/mg, which is calibrated against rHuIFN-γ WHO International Standard (NIBSC code: 87/586).
Assay #2: The ED50 as determined by a cytotoxicity assay using human MCF-7 cells is less than 14 ng/mL.
Appearance
Sterile filtered white lyophilized (freeze-dried) powder.
Formulation
Lyophilized from a 0.2 µm filtered concentrated solution in PBS, 3% Trehalose, pH 5.0.
Stability & Storage
Use a manual defrost freezer and avoid repeated freeze-thaw cycles.
- A minimum of 12 months from date of receipt, when stored at ≤ -20 °C as supplied.
- 1 month, 2 to 8 °C under sterile conditions after reconstitution.
- 3 months, -20 to -70 °C under sterile conditions after reconstitution.
- Refer to lot-specific CoA for the Expiry Date.
Shipping
The product is shipped with polar packs. Upon receipt, store it immediately at the temperature recommended below.
Endotoxin
Less than 0.01 EU/µg of rHuIFN-γ GMP as determined by LAL method.
Host Cell Protein
Less than 0.05% when tested by ELISA.
Host Cell DNA
Less than 20 ng/mg when tested by qPCR.
Reconstitution
Prior to opening, it is recommended to centrifuge the vial briefly to bring the contents down the bottom. Reconstitute in sterile distilled water or aqueous buffer containing 0.1% BSA to a concentration of 0.1-1.0 mg/mL. If animal-origin-free condition is expected in your product, then sterile distilled water is recommended. Stock solutions should be apportioned into working aliquots and stored at ≤ -20 °C. Further dilutions should be made in appropriate buffered solutions.
Usage
This material is offered by Shanghai PrimeGene Bio-Tech for research, laboratory, or further evaluation purposes. NOT FOR HUMAN USE.
Quality Statement
The manufacturing and testing of these products comply with ICH Q7 guidelines.
Background
Interferon-gamma (IFN-γ), also known as Type II interferon or immune interferon, is a cytokine produced primarily by T-lymphocytes and natural killer cells. The protein shares no significant homology with IFN-β or the various IFN-α family proteins. Mature IFN-γ exists as noncovalently-linked homodimers. Human IFN-γ is highly species specific and is biologically active only in human and primate cells. IFN-γ was originally characterized based on its antiviral activities. The protein also exerts antiproliferative, immunoregulatory and proinflammatory activities and is thus important in host defense mechanisms. IFN-γ induces the production of cytokines, upregulates the expression of class I and II MHC antigens, Fc receptor and leukocyte adhesion molecules. It modulates macrophage effector functions, influences isotype switching and potentiates the secretion of immunoglobulins by B cells. IFN-γ also augments TH1 cell expansion and may be required for TH1 cell differentiation.
